US Drug Recall Register

FDA Drug Recalls

14,450 recalls · Class II, newest first

Risk Class IClass IIClass III
Status OngoingCompletedTerminated
Year 2026202520242023
Class II · Moderate risk Terminated

Dmps Acid *5ml* Sdv 50mg/Ml Inj

Reason Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

Key Pharmacy and Compounding Center D-0714-2017
Class II · Moderate risk Terminated

Co-Q-10 Oil 20ml Mdv

Reason Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

Key Pharmacy and Compounding Center D-0713-2017
Class II · Moderate risk Terminated

Atropine Sulfate 0.5% Ophth

Reason Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

Key Pharmacy and Compounding Center D-0712-2017
Class II · Moderate risk Terminated

Atropine Sulfate 0.01% Ophth

Reason Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

Key Pharmacy and Compounding Center D-0711-2017
Class II · Moderate risk Terminated

5-Mthf Sdv 5mg/Ml Inj

Reason Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

Key Pharmacy and Compounding Center D-0710-2017
Class II · Moderate risk Terminated

5-Mthf 10ml Sdv

Reason Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

Key Pharmacy and Compounding Center D-0709-2017
Class II · Moderate risk Terminated

5-Mthf 10ml Mdv

Reason Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

Key Pharmacy and Compounding Center D-0708-2017
Class II · Moderate risk Terminated

5-Mthf *10ml* Mdv 5mg/Ml Inj

Reason Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

Key Pharmacy and Compounding Center D-0707-2017
Class II · Moderate risk Terminated

Riomet

Reason Microbial Contamination of Non-Sterile Products

Sun Pharmaceutical Industries, Inc. NDC 10631-206-01 D-0109-2018
Class II · Moderate risk Terminated

Estrone USP

Reason cGMP Deviations; lack of quality assurance.

American Pharmaceutical Ingredients LLC D-0919-2017
Class II · Moderate risk Terminated

Eemt

Reason CGMP deviations: Lots were recalled due to sub-potency and cGMP violations.

Syntho Pharmaceuticals, Inc. NDC 15310-010-01 D-0378-2019
Class II · Moderate risk Terminated

Eemt Hs

Reason CGMP deviations: Lots were recalled due to sub-potency and cGMP violations.

Syntho Pharmaceuticals, Inc. NDC 15310-020-01 D-0377-2019
Class II · Moderate risk Terminated

Levonorgestrel

Reason CGMP Deviations: these repackaged and redistributed products are being recalled due to a recall notice from the active pharmaceutical ingredient manufacturer for deviations from current Good Manufacturing Practices that were found during a recent FDA inspection.

Spectrum Laboratory Products, Inc. D-0882-2017
Class II · Moderate risk Terminated

Estradiol

Reason CGMP Deviations: these repackaged and redistributed products are being recalled due to a recall notice from the active pharmaceutical ingredient manufacturer for deviations from current Good Manufacturing Practices that were found during a recent FDA inspection.

Spectrum Laboratory Products, Inc. D-0881-2017
Class II · Moderate risk Terminated

Fentanyl Citrate

Reason Labeling: Not Elsewhere Classified- Diluent used to compound product expired prior to the expiration date assigned to the compounded product.

PharMedium Services, Llc NDC 61553-605-52 D-1166-2017
Class II · Moderate risk Terminated

Fentanyl Citrate

Reason Labeling: Not Elsewhere Classified- Diluent used to compound product expired prior to the expiration date assigned to the compounded product.

PharMedium Services, Llc NDC 61553-112-52 D-1165-2017
Class II · Moderate risk Terminated

Estrone

Reason cGMP Deviations: lack of quality assurance at the API manufacturer.

Fagron, Inc NDC 51552-0445-2 D-0792-2017
Class II · Moderate risk Terminated

Estriol

Reason cGMP Deviations: lack of quality assurance at the API manufacturer.

Fagron, Inc NDC 52372-9292-01 D-0791-2017
Class II · Moderate risk Terminated

Phenylephrine 2.5%

Reason Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.

Isomeric Pharmacy Solution, LLC D-0687-2017
Class II · Moderate risk Terminated

Testosterone Cypionate 200 mg/mL

Reason Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.

Isomeric Pharmacy Solution, LLC D-0686-2017
Class II · Moderate risk Terminated

Triamcinolone Diacetate 40 mg/mL

Reason Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.

Isomeric Pharmacy Solution, LLC D-0684-2017
Class II · Moderate risk Terminated

Triamcinolone Acetonide 40 mg/mL

Reason Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.

Isomeric Pharmacy Solution, LLC D-0683-2017
Class II · Moderate risk Terminated

Methylprednisolone Acetate 80 mg/mL

Reason Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.

Isomeric Pharmacy Solution, LLC D-0682-2017
Class II · Moderate risk Terminated

Methylprednisolone Acetate 40 mg/mL

Reason Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.

Isomeric Pharmacy Solution, LLC D-0681-2017